http://www.fiercepharma.com/pharma/roche-sues-amgen-says-its-delay-biosimilar-patent-battle-potentially-disasterous The law says in one pathway to approval, once the FDA accepts an Abbreviated Biologic License Application for the biosimilar, the applicant has 20 days to provide the drug’s originator the aBLA and “such other information that describes the process or processes used to manufacture the biological product.” Then the originator, Genentech in this case, has 60 days to review it with experts and say what patents it believes might be infringed and how. The clock started to tick Jan. 4 when the FDA accepted Amgen’s application. But Roche says Amgen has provided only its aBLA, claiming that satisfied its obligation and should be all Roche needs to do its evaluation. It also blasts Amgen in the filing for an “about-face.” It points out that Amgen had a different attitude when one of its own drugs was under attack by a biosimilar. When “Hospira, produced only its aBLA after applying for FDA approval for a biosimilar of Amgen’s blockbuster Epogen —exactly the same conduct Amgen has engaged in here—Amgen sued Hospira in this district for noncompliance with the BPCIA....” the filing says. In that case, Amgen argued "a patent owner cannot fully protect itself as Congress intended if the applicant only produces its aBLA, because many important details about the product are normally omitted,” Roche declares in its filing AMGEN TALKING OUT OF ITS ASS! AMGEN SHIT DONT STINK! OBU WILL ONE DAY SELL A BLOCKBUSTER ONCOLOGY THERAPEUTIC -- TOO BAD IT WILL BE DECADES OLD AVASTIN/HERCEPTIN BIOSIMILAR! ASK HOW THE ENBREL REPS LIKE SELLING A DRUG WITH NO NEW DATA IN 10 YEARS THAT SHOULD HAVE BEEN OFF PATENT!
I love how Genentech people have to come on the Amgen board all of the time. Several posts on the Amgen board recently that obviously stem from Roche drones. Pathetic. I read this article before seeing it on CP. Immediately, I knew Genentech folks would freak out. Glad to see they are as predictable as I suspected. Truth is, it's called smart business. Why wouldn't Amgen try to protect it's own intellectual property, while trying to develop biosimilars of oncology products that are worth billions of dollars? Any business savvy company would make the same moves. In fact, if Amgen didn't play both sides of this debate, as a stock holder, I would be concerned. I am relieved to read this article and know my Amgen stock is in good hands.
Still doesn't change Amgen being a second rate supportive care/generics company with D level talent. Also you don't own enough shares to change you lifestyle either way.
Whatever you have to tell yourself so that you can sleep at night. Since you don't work here and spend so much time trashing Amgen, that tells me a lot. If you didn't see Amgen as a threat, you wouldn't waste your time coming on this board. I find that people who are secure, successful, and happy don't go around posting on competitors CP boards. Just sayin'.
You sound like a corporate cocksucker. No original thought. That's Amgen DM material right here folks. The reality whether you like it or not, Amgen is hypocritical. They want one set of rules to not apply to them, but only to others in their industry. You want cake and to eat it too. This was never about the patients. This is all about greed. The sad thing about the OBU is that their products suck so bad that the best thing for them is someone else aging product. You are at Amgen because no else will hire you.
